Prevention of Post-operative Urinary Retention

PHASE3CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

April 1, 2018

Study Completion Date

May 2, 2018

Conditions
Urinary RetentionUrinary Tract Infections
Interventions
DRUG

Tamsulosin

"Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.~Outline of schedule:~* Day 1-7: tamsulosin 0.4mg in the evening~* Day 8: surgery; tamsulosin 0.4mg in the evening if the subject has not yet completed the bladder management protocol~* Day 9-14: tamsulosin 0.4mg in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual \<200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function."

DRUG

Placebo

"Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.~Outline of schedule:~* Day 1-7: placebo in the evening~* Day 8: surgery; placebo in the evening if the subject has not yet completed the bladder management protocol~* Day 9-14: placebo in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual \<200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function."

Trial Locations (1)

53792

University of Wisconsin Hospital and Clinics, Madison

All Listed Sponsors
lead

University of Wisconsin, Madison

OTHER

NCT02486653 - Prevention of Post-operative Urinary Retention | Biotech Hunter | Biotech Hunter